Phase 3 – Page 6 – Communicable Diseases Research

Innovative clinical trial design and delivery: a phase 3 COVID-19 post-exposure prophylaxis study in skilled nursing and assisted living facilities (BLAZE-2)

혁신적인 임상 시험 설계 및 전달: 전문 간호 및 생활 보조 시설(BLAZE-2)에서 COVID-19 노출 후 예방 연구 3상

Randomized Controlled Trial

Published on 2021-10-212022-09-10
Journal: Trials [Category] MERS, SARS, 임상,

Efficacy of typhoid conjugate vaccine in Nepal: final results of a phase 3, randomised, controlled trial

네팔에서의 장티푸스 결합 백신의 효능: 3상 무작위 대조 시험의 최종 결과

Articles

Published on 2021-10-192022-10-30
Journal: The Lancet. Global health [Category] COVID-19, 살모넬라증,

Efficacy and safety of pegylated interferon-α2b in moderate COVID-19: a phase 3, randomized, comparator-controlled, open-label study

중등도 COVID-19에서 페길화된 인터페론-α2b의 효능 및 안전성: 3상, 무작위, 비교 대조, 공개 라벨 연구

Clinical Trial

Published on 2021-10-012022-09-11
Journal: International Journal of Infectious Diseases [Category] SARS, 바이오마커, 임상, 치료제,

[키워드] 1:1 acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus-2 Administered adult subject adult subjects alpha-2b Arm ARMS Biomarker Biomarkers clinical status clinically conjunction coronavirus disease Coronavirus disease-19 Coronavirus-2 COVID-19 Day decrease Efficacy and safety evaluate Health Organization IFN IFN-α2b interferon interferon alpha-2b Laboratory parameters limit moderate Moderate COVID-19 Moderate subjects Open-label Ordinal Scale oxygen Pegylated interferon alpha-2b (PEG IFN-α2b) phase Phase 3 primary endpoint proportion provide Randomized receive safety profile SARS-CoV-2 seven-point ordinal scale severe acute respiratory syndrome Coronavirus severe acute respiratory syndrome coronavirus-2 significant changes in Spread Standard of care subject subjects supplemental oxygen viable treatment viral clearance World Health Organization
[DOI] 10.1016/j.ijid.2021.08.044 PMC 바로가기 [Article Type] Clinical Trial

Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine

AZD1222(ChAdOx1 nCoV-19) 코로나19 백신 3상 안전성 및 효능

Clinical Trial

Published on 2021-09-292022-09-25
Journal: The New England Journal of Medicine [Category] Fulltext, SARS, 신약개발, 임상, 진단, 치료법,

[키워드] 95% CI 95% confidence interval acute respiratory syndrome Adults adverse event age Analysis antibody AstraZeneca AZD1222 binding ChAdOx1 nCoV-19 clinical trial coronavirus Critical dose double-blind Efficacy first dose generally mild in both groups incidence increased risk Infection investigated Local moderate neutralizing antibody nucleocapsid Older participant Participants phase Phase 3 Placebo placebo-controlled Population randomization Randomized receive Result Safe Safety SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 spike protein second dose Seroconversion severe coronavirus disease subgroups symptomatic symptomatic COVID-19 systemic reaction the placebo group The United States Vaccine
[DOI] 10.1056/NEJMoa2105290 PMC 바로가기 [Article Type] Clinical Trial

Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19

Molnupiravir에 대한 발견, 개발 및 특허 동향: COVID-19에 대한 유망한 경구 치료제

Review

Published on 2021-09-242022-09-10
Journal: Molecules [Category] SARS, 임상, 치료제,

Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase

맹검 단계 완료 시 mRNA-1273 SARS-CoV-2 백신의 효능

Clinical Trial

Published on 2021-09-222022-09-25
Journal: The New England Journal of Medicine [Category] Fulltext, MERS, 신약개발, 임상, 진단,

[키워드] 1:1 95% CI 95% confidence interval acute respiratory syndrome age Analysis assigned asymptomatic infection authority baseline blinded completion conditions confirmed case coronavirus coronavirus disease Cutoff development Efficacy Efficacy and safety Emergency use enrolled Evidence Follow-up groups high risk include injection Injections interim analysis Intramuscular injection mRNA-1273 mRNA-1273 vaccine observer-blinded Open-label participant phase Phase 3 Placebo placebo-controlled clinical trial primary end point protocol Racial Randomly receive reported Result safety profile SARS-CoV-2 SARS-COV-2 infection severe disease the median the placebo group The United States the vaccine Trial vaccine efficacy Volunteer
[DOI] 10.1056/NEJMoa2113017 PMC 바로가기 [Article Type] Clinical Trial

Hand hygiene compliance of healthcare workers before and during the COVID-19 pandemic: A long-term follow-up study

Observational Study

Published on 2021-09-012022-10-05
Journal: American journal of infection control [Category] 임상,

Validation and implementation of a direct RT-qPCR method for rapid screening of SARS-CoV-2 infection by using non-invasive saliva samples

비침습적 타액 샘플을 사용하여 SARS-CoV-2 감염의 신속한 스크리닝을 위한 직접 RT-qPCR 방법의 검증 및 구현

Article

Published on 2021-09-012022-09-11
Journal: International Journal of Infectious Diseases [Category] SARS, 치료기술,

[키워드] 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Asymptomatic Barcelona comparable conducted coronavirus COVID-19 diagnostic diagnostic sensitivity Direct health worker hospital implementation less nasopharyngeal specimen Non-invasive participant PCR Phase 1 Phase 2 Phase 3 pilot screening positive positive result processed RNA RNA extraction RT-qPCR Saliva saliva samples SARS-CoV-2 SARS-COV-2 infection scaled up Screening screening method Sensitivity and specificity severe acute respiratory syndrome Coronavirus Spain supervision Surveillance validation virus inactivation
[DOI] 10.1016/j.ijid.2021.07.054 PMC 바로가기 [Article Type] Article

FDA-authorized mRNA COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system

FDA 승인 mRNA COVID-19 백신은 여러 주 의료 시스템에서 합성된 실제 증거에 따라 효과적입니다.

Article

Published on 2021-08-132022-09-11
Journal: Med (New York, N.Y.) [Category] Coronavirus, SARS, 임상, 진단,

[키워드] 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Admission BNT162b2 Clinical outcome clinical outcomes clinical trials Cohort coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 vaccines demonstrated dose drug Drug administration effective Effectiveness Efficacy Evidence Features food health system Healthcare system Hospitalization ICU ICU admission incidence rate incidence rates individual intensive care Mayo Clinic Moderna mRNA mRNA COVID-19 vaccine mRNA vaccines mRNA-1273 PCR testing Pfizer/BioNTech Phase 3 positive propensity score matching randomized clinical trials real world evidence. reduced Retrospective analysis SARS-CoV-2 SARS-COV-2 infection Vaccine vaccine dose
[DOI] 10.1016/j.medj.2021.06.007 PMC 바로가기 [Article Type] Article

Readability of Participant Informed Consent Forms and Informational Documents: From Phase 3 COVID-19 Vaccine Clinical Trials in the United States

Research article

Published on 2021-08-012022-10-05
Journal: Mayo Clinic proceedings [Category] 임상,

[키워드] analyzed assessments AstraZeneca average CDCCenters for Disease Control and Prevention Centers for Disease Control and Prevention CFRCode of Federal Regulations clinical clinical study clinical trial clinical trials Code of Federal Regulations conducted consent form Coronavirus disease 2019 COVID-19 COVID-19 vaccine COVID-19 vaccine trial COVID-19coronavirus disease 2019 Department of Health and Human Services DHHSDepartment of Health and Human Services English Factors FDAFood and Drug Administration Food and Drug Administration form forms greater information Informed informed consent form Johnson & Johnson Microsoft Word Moderna Novavax objective Office of Human Research Protection OHRPOffice of Human Research Protection participant Patient Pfizer phase Phase 3 provided Readability receive Research Result subject the United State The United States Vaccine vaccine trial were used written consent
[DOI] 10.1016/j.mayocp.2021.05.025 [Article Type] Research article